"We have five different vaccines undergoing trials"

Q Kindly elaborate on the nature of your agreement with AstraZeneca. Is it with the global company or with the Indian subsidiary? Also, is AZ going to provide the technology for the Covid-19, or is Serum Institute a participant in the development research as well?

A Serum Institute of India has entered into a manufacturing partnership with AstraZeneca (Global) to produce and supply the Oxford vaccine candidate for Covid-19 across India and other low-and-middle-income countries (GAVI countries). Our facilities are well-equipped with the latest technology to develop and commence mass-production of the vaccine after getting regulatory approvals. 

Q You have mentioned that clinical trials for the Oxford-AZ vaccine would involve about 4,000-5,000 subjects. Which phase would these trials belong to – Phase 1 or 2? Is it correct to say that many of these subjects are employees of Serum Institute?

A We expect to commence Phase 3 human trials in India around August 2020, with 4,000-5,000 patients in India. We can confirm the details of the trials once we receive all the requisite approvals. We plan to conduct these trials in Mumbai and Pune, as they are the main hotspots. I am sure that we will get enough people to volunteer for the trials. 

Q In a recent TV interview, you are reported to have said that you have about five different agreements underway. Are all these for Covid-19 vaccines or for different diseases? And how would these help to reduce the potential losses in case the Oxford-AZ vaccine does not work out in the end? 

A The world needs an immunogenic vaccine to fight the virus and we are committed to bring one at the earliest. Given the severity and the urgency of the situation, we did not want to rely on just one candidate. In case, one candidate didn’t work, we wanted to have an alternate course of action. This is why we have tied up with five vaccine candidates against Covid-19. Two of which are our own candidates. We hope to announce the availability of our own vaccines by the end of 2021. As per our associations, we are to manufacture and distribute the Novavax candidate across GAVI nations. The Codagenix vaccine is expected to progress soon and we have a global manufacturing and supply association with them. We have also tied up with a company for an mRNA vaccine candidate and hope to announce that soon. 

Q Recently, Serum announced the DCGI approval for a pneumococcal conjugate vaccine that had been under clinical trials since 2013. Where does this fit into Serum’s overall scheme of things?

A Serum Institute had first obtained the approval of DCGI to conduct clinical trials in Phases I, II and III. Post reviewing the clinical data, the company got permission to manufacture its own indigenously developed pneumococcal vaccine. This is a pneumococcal polysaccharide conjugate vaccine that took five years to develop and conduct multi-centric global trials before it was licensed. The vaccine is used for active immunisation against invasive disease and pneumonia caused by Streptococcus pneumoniae in infants. 

Q What is the total number of vaccine doses that Serum produces each year? And if you plan to produce 300-400 million doses of the Covid-19 vaccine in 2021, how much of the company’s resources would this demand?

A On average, Serum Institute of India produces and sells (more than 1.5 billion doses) globally which includes Polio vaccine as well as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. Presently, keeping in mind the pandemic situation, we have dedicated two of our facilities to produce millions of doses for Covid-19 vaccine, while withholding vast production of other products.

Q You have spoken about a possible $200 million hit in the event that the Oxford-AZ vaccine fails the final tests. Does this include the peripheral and preparatory expenses as well as the budget outlay on the clinical trials?

A Yes, we will incur losses in case the vaccine fails. It includes the peripheral and preparatory expenses of raw materials, and human resources. We are yet to begin with the clinical trials. We will be able to comment on this once we have all the requisite licensure trials approvals.